Prospective Randomized Double Blind Clinical Trial of Polyhexamethylene Biguanide Impregnated Foam Dressing

This is a multi-center, prospective, randomized, double blind, pilot clinical trial of subjects with chronic wounds. The purpose of this study is to compare the efficacy of COPA AMD PHMB Impregnated foam dressing compared to regular foam dressing in subjects with chronic wounds.

Study Overview

• Status: Completed
• Conditions: Wounds
• Intervention / Treatment: Device: COPA AMD (note: name is not an acronym); Device: COPA (note: name is not an acronym)

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L4Y 1A6
      • Community Dermatology and Wound Healing Clinic
    • Toronto, Ontario, Canada, M5S 1B2
      • Women's College Hospital; Dermatology Daycare & Wound Healing Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• subject is 18 to 85 years of age inclusive
• subject has a foot ulcer
• subject has a leg ulcer
• subject has an open wound of at 1.0 cm (2)
• subject has one of the following: Palpable pulse, ABI > 0.56 or toe pressure > 50 mmHg
• subject or legally authorized rep is able to understand and willing to give written informed consent

Exclusion Criteria:

• subject has an allergy to Chlorhexidine Gluconate (CHG)
• subject has open wounds that in the opinion of the Principal Investigator do not have the ability to heal
• subject has current malignant disease or history of malignant disease in past 5 years
• subject has inability to comply with the study protocol and procedures
• subjects who require use of topical agents other than the impregnated or regular foam dressings dressings

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 2	Device: COPA (note: name is not an acronym); Regular foam dressing without PHMB
Active Comparator: Arm 1	Device: COPA AMD (note: name is not an acronym); Foam dressing impregnated with Polyhexamethylene Biguanide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups		5 weeks
Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0.	At each study visit, the subject's wound surface area was measured by longest length times widest width at right angles (LxW=cm2). Compiled data were analyzed to determine the median percentage decrease in wound surface area between groups and between study visits. Results report the median percentage decrease of the wound surface area as measured by cm2, comparing wound surface area at Week 4 to Week 0.	Weeks 0 and 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain	5 weeks

Collaborators and Investigators

• Sponsor: Tyco Healthcare Group
• Investigators: Principal Investigator: R. Gary Sibbald, MD, Community Dermatology and Wound Healing Clinic, Women's College Hospital- Dermatology Daycare & Wound Healing Clinic

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: January 10, 2008
• First Submitted That Met QC Criteria: February 6, 2008
• First Posted (Estimate): February 20, 2008

Study Record Updates

• Last Update Posted (Estimate): April 15, 2010
• Last Update Submitted That Met QC Criteria: April 9, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: 360.18